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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

EU Parliament Committee Backs Report to Increase Access to Medicines

The European Parliament’s Environment, Public Health and Food Safety (ENVI) committee on Tuesday backed a draft report calling on the commission to analyze the impact of intellectual property on pharmaceutical access, as well as review the regulatory framework for orphan medicines, among other provisions.

The draft, which a spokeswoman for the European Parliament told Focus that a final version will be made public by the end of this week, covers a menagerie of different topics including: the price of medicines, unaffordability, barriers to access, drug shortages, research and development priorities, cost transparency, the urgency of antimicrobial resistance threats, national and regional health technology assessment (HTA) and harmonized criteria to assess the added therapeutic value compared with the best available alternatives, as well as the measures to reinforce the use of generics and biosimilars.

Industry group EFPIA praised the move in a statement, saying it supports the ENVI committee recommendation “on the need for a stable and predictable intellectual property and regulatory framework, which is essential to create and maintain an innovation-friendly environment, supporting patient access to innovative treatments.”

Miriam Dalli, spokesperson for health of the Group of the Progressive Alliance of Socialists & Democrats in the European Parliament, also said in a statement: "The increasingly high cost of medicines and shrinking public health budgets have seriously jeopardised affordable access to essential medicines. Insufficient access to essential medical products poses a serious threat to the well-being of whole sections of the population in Europe. It is imperative that we establish cooperation programmes on research and development and innovative technologies to ensure that the needs of the most vulnerable are properly addressed.”

“After many debates, the Parliament is aligning with the Council to make competition from generic, biosimilar and value added medicines a high priority in policies to support access to medicines,” Adrian van den Hoven, Medicines for Europe Director General, said.